What You Need to Know to Participate

Study Title	Porn Abstinence Impact Challenge: Stress Test
Principal Investigator	Matthew Amsden
Subinvestigator(s)	Viral Patel, MD
Study Author(s)	Jordan Tsanev, Christos Konstantinidis, Matthew Amsden
Cost to Participate	Free
Included Products & Services	This study includes no additional products or services.
Outcome Measures	Weekly Porn Consumption Survey, Sexual Desire Inventory-2 (SDI-2), International Index of Erectile Function, Perceived Stress Scale
Key Responsibilities	Follow the 40-day timeline, complete weekly check-ins, report issues, and abstain from pornography during the abstinence phase.
Known Risks	You may become bored or uncomfortable when answering some of the questions.  Some questions may cause embarrassment or stress.
Possible Benefits	Potential improved self-awareness, potential behavioral insight, contribution to scientific research.  There is a possibility that there will be no measurable benefit to you.
Contact for Questions	Email: help@efforia.com Phone Number: (646) 679-2479 Or click the chat button on your screen

👍 This table gives you the essentials. If you’d like more detail on any topic above—including risks, benefits, data privacy, or withdrawal rights—please read the full consent document below.

Introduction and Summary

Welcome to this exciting opportunity to join our research study on the Efforia platform. This study is possible thanks to your participation. We're here to help you explore the reasons you might want to join this study, or why it might not be right for you. Our goal is to understand the effects of abstaining from pornography over a 40-day period. Your participation is voluntary, and you can leave the study at any time without penalty. We encourage you to ask any questions you may have before deciding to join.

Purpose of the Study

The Porn Abstinence Impact Challenge: Stress Test study aims to investigate the effects of abstaining from pornography on stress regulation, sexual performance, and emotional resilience. By using a series of surveys including the Sexual Desire Inventory-2 (SDI-2) and the Perceived Stress Scale, we aim to contribute to scientific knowledge about personal behavior changes and their broader impact on society. If you decide to participate, you will be asked to engage in self-assessment activities that enhance awareness and potentially inform personal health decisions. 

The number of participants in this study will be determined by the number of people willing to sign up.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or via online chat.

The study involves a structured timeline of 40 days, divided into two distinct phases. During the first week, you will be asked to maintain your regular pornography usage habits to establish a baseline. This period is important for collecting information regarding your current mental, physical, and emotional state without any modifications.  You will be asked to complete the following surveys:

• Weekly Porn Consumption Survey: Questions about your use of pornography over the last week.
• Sexual Desire Inventory: Questions about your interest in engaging in sexual activity. 
• International Index of Erectile Function Survey: Questions about your sexual functioning and experiences. 
• Perceived Stress Scale: Evaluates stress levels based on recent experiences within the last week.

Following the initial week, you will enter a 30-day abstinence period, starting on Day 8, where you will attempt to refrain from any form of pornography. This phase is designed to observe the effects of abstinence on stress regulation, sexual performance and arousal, energy, focus, motivation, and emotional resilience.

Throughout the study, you will be asked to perform weekly check-ins using the surveys above to track your progress, providing insights into personal behavior changes and impacts. These activities are essential for the real-time adjustment, observation, and reflection of your experiences.

It is important that you follow the schedule to make sure the study results are reliable. You are encouraged to use linked tools like Google Calendar and Todoist to maintain consistency in check-ins and reflections, with privacy and data security being a top priority.

Will There be Any Costs?

There is no cost to you for your study participation.

Will I be Paid for Participating?  

You will not be paid for participating in this study. 

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall study findings as they become available. These findings may impact your interest and willingness to stay in the study. Participation is voluntary, and you may stop the study at any time by emailing help@efforia.com.

Benefits of Being in the Study

Participating in this study may provide personal insights into your behavior, stress levels, and sexual health. You'll have the opportunity to engage in self-reflection and potentially make informed personal health decisions based on your findings. Additionally, your participation may contribute to broader scientific knowledge that may benefit others. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention had no measurable impact.

Risks Related to Study Participation

It is your responsibility to weigh the risks and benefits and decide if you should participate. You are encouraged to consult with your healthcare providers and conduct further research before enrolling in the study.

Known Risks

It is expected that the study will pose no more than minimal risk to you.  In this study, you will be asked to complete questionnaire[s] which include questions about your use of pornography and sexual activity.  You may become bored or uncomfortable when answering some of the questions.  Some questions may cause embarrassment or stress.  

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical support or emergency services. You are advised to rely on your healthcare providers throughout the study for ongoing health issues or in the event of side effects.  

Privacy and Security Risks

Your research records will be kept confidential to the extent permitted by applicable laws and/or regulations. Efforts will be made to keep your personal information private, however, total confidentiality cannot be guaranteed.   The results of this study may also be published or presented at medical meetings, but your identity will not be disclosed. 

You should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

There may be very certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the US Food and Drug Administration (FDA) or similar agency, or Institutional Review Boards may review records that have your identifying information.

What to do if you have a study related injury

If you experience a study-related injury, please seek local medical care first if necessary. Efforia cannot provide emergency medical care. However, it is important to contact Efforia if you experience any problems, have any side effects, or have any study-related injury after you've received the necessary treatment. You can contact Efforia at the contact details provided in the beginning of this consent.

Study related injury care and compensation

Efforia does not plan to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. You will need to access local in-person medical assistance immediately.  You should contact Efforia after the emergency has passed. If at any time during the study you have any thoughts of hurting yourself or someone else, you can call the toll-free 24-hour National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or call or text 988.  

Alternatives to Participating in the Study

You do not have to take part in this study.  The alternative is you can choose not to participate.

Your Rights as a Participant

Your participation in this study is completely voluntary, and you are free to withdraw at any time without any consequences. You are not giving up any rights by signing this document.

Right to Your Own Results

You have the right to a complete explanation of the research once your participation has ended.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." 

We will tell you of any information learned during this study that might cause you to change your mind about continuing to take part.   

Conflict of Interest Statement

As part of our commitment to ethical conduct and openness in our citizen science clinical trial, it is important to explain the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves as the platform provider and does not sponsor or influence the study outcomes.

To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

It is important that participants do not have any financial relationship with the intervention methods or measurement providers used in the study, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly affect the study's integrity and the results.

Consequences of Conflict of Interest Non-Compliance

Should you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform.

By joining this study, you affirm that you understand the above conflict of interest restrictions and agree to follow them. Your participation is valued, and your commitment to following these guidelines helps make sure that our collective scientific efforts are accurate and reliable.

Data Protections

Efforia is committed to protecting your data. Efforia ensures that data will be collected, used, and protected in compliance with data protection laws.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, please do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy.

Who will have access to your data?

Efforia will have access to your data. There may also be partners who have access to your data.

What will we do with your data

We will use the data to show you your own personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

California Experimental Research Subject’s Bill of Rights

You are encouraged to review the California Experimental Research Subject Bill of Rights. Full details on your privacy and data protection rights can be found in Efforia's privacy policy, accessible at https://efforia.com/privacy-policy.

A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results. You can search this Web site at any time.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:

Email: HELP@EFFORIA.COM
Phone Number: (646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN

If you are unable to reach anyone with the contact information listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.

An institutional review board (IRB) is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.